Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder:Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial

Abstract Background Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the \u201cThe Unified Protocol for Transdiagnostic Treatment of Emotional Disorders\u201d (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT. Methods/design The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6\ua0months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence. Discussion The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in psychotherapy and the association between patient characteristics and treatment effect. Trial registration Clinicaltrials.gov NCT02954731 . Registered 25 October 201

Social phobia and evasiveness: trial protocol for a randomized controlled feasibility and superiority trial of the effect of Modified Collaborative Assessment vs. standard assessment on patients’ readiness for psychotherapy (CO-ASSM-RCT)

Abstract Background Evasive personality disorder (AvPD) and social phobia (SP) have substantial costs for patients and their families and great economic costs to the society. While psychotherapy can be an efficacious treatment, many patients drop out during treatment. Increased knowledge on how to decrease dropout from psychotherapy is warranted, including how to increase a patient’s readiness for psychotherapy. Methods We describe a randomized controlled feasibility and superiority trial of 42 individuals with a clinical diagnosis of either SP or AvPD, who are to initiate psychotherapeutic treatment in Danish outpatient mental health services. They will be randomized in a 1:1 ratio to either assessment-as-usual and receive no further assessment or to a Modified Collaborative Assessment (MCA) provided as a pre-treatment intervention before psychotherapy initiation. MCA will include a battery of psychological tests designed to thoroughly assess the patients’ psychopathology. The tests are administered in collaboration with the patient, including detailed oral and written feedback. We hypothesize that the intervention is feasible regarding patient’s acceptance and adherence. We further hypothesize that patients randomized to MCA will reach higher levels of readiness for psychotherapy as assessed with the University of Rhode Island Change Assessment Scale (URICA). Discussion This protocol assesses the feasibility, efficacy, acceptability, and safety of an intervention aimed at changing the readiness for participation in psychotherapy of patients with SP and AvPD. Results from this feasibility study could guide the development of future large-scale trials of MCA and procedures for MCA treatment fidelity assessment. Trial registration NCT2021001

“Despite the Differences, We Were All the Same”. Group Cohesion in Diagnosis-Specific and Transdiagnostic CBT Groups for Anxiety and Depression: A Qualitative Study

Group cohesion refers to a sense of belonging, mutual support and identification with other group members. Group cohesion has been associated with better outcomes, lower drop-out rates, more interpersonal support and better participation in psychotherapy. Nevertheless, the role of group cohesion in CBT has not yet received much attention. The rationale for delivering CBT in groups is that patients can model themselves through each other due to their similarities in symptoms. However, there has recently been a shift towards transdiagnostic CBT protocols, in which patients with varied diagnoses participate in the same groups. This shift challenges the rationale of delivering CBT in groups, and it is therefore highly important to understand if and how group cohesion develops in mixed diagnoses CBT groups. The current study used a qualitative comparative framework to investigate the patients’ experiences of group cohesion in diagnosis-specific versus transdiagnostic CBT groups. Twenty-three patients were interviewed with semi-structured interviews upon completion of the treatment. Participants had a primary diagnosis of MDD, panic disorder, agoraphobia or social anxiety disorder. A comparative thematic analysis was carried out. Three themes were found: the move from differences to similarities, the role of group cohesion in group CBT and factors helpful and hindering to group cohesion. Group cohesion developed across groups and was considered highly important in both diagnosis-specific and transdiagnostic CBT groups

Personalized Psychotherapy for Outpatients with Major Depression and Anxiety Disorders: Transdiagnostic Versus Diagnosis-Specific Group Cognitive Behavioural Therapy

Background: Only about half of all patients with anxiety disorders or major depression respond to cognitive behaviour therapy (CBT), even though this is an evidence-based treatment. Personalized treatment offers an approach to increase the number of patients who respond to therapy. The aim of this study was to examine predictors and moderators of (differential) treatment outcomes in transdiagnostic versus diagnosis-specific group CBT. Methods: A sample of 291 patients from three different mental health clinics in Denmark was randomized to either transdiagnostic or diagnosis-specific group CBT. The study outcome was the regression slope of the individual patient's repeated scores on the WHO-5 Well-being Index. Pre-treatment variables were identified as moderators or predictors through a two-step variable selection approach. Results: While the two-step approach failed to identify any moderators, four predictors were found: level of positive affect, duration of disorder, the detachment personality trait, and the coping strategy of cognitive reappraisal. A prognostic index was constructed, but did not seem to be robust across treatment sites. Conclusions: Our findings give insufficient evidence to support a recommendation of either transdiagnostic or diagnosis-specific CBT for a given patient or to predict the response to the applied group therapies

Personalized Psychotherapy for Outpatients with Major Depression and Anxiety Disorders:Transdiagnostic Versus Diagnosis-Specific Group Cognitive Behavioural Therapy

Background: Only about half of all patients with anxiety disorders or major depression respond to cognitive behaviour therapy (CBT), even though this is an evidence-based treatment. Personalized treatment offers an approach to increase the number of patients who respond to therapy. The aim of this study was to examine predictors and moderators of (differential) treatment outcomes in transdiagnostic versus diagnosis-specific group CBT. Methods: A sample of 291 patients from three different mental health clinics in Denmark was randomized to either transdiagnostic or diagnosis-specific group CBT. The study outcome was the regression slope of the individual patient's repeated scores on the WHO-5 Well-being Index. Pre-treatment variables were identified as moderators or predictors through a two-step variable selection approach. Results: While the two-step approach failed to identify any moderators, four predictors were found: level of positive affect, duration of disorder, the detachment personality trait, and the coping strategy of cognitive reappraisal. A prognostic index was constructed, but did not seem to be robust across treatment sites. Conclusions: Our findings give insufficient evidence to support a recommendation of either transdiagnostic or diagnosis-specific CBT for a given patient or to predict the response to the applied group therapies